The Japanese Ministry of Health, Labor and Welfare granted a marketing authorization this week for the monoclonal antibody romosozumab for the treatment of osteoporosis in patients at high risk for fracture, Amgen and UCB Pharma announced in a press release.

"The approval of Evinity in Japan is a significant milestone that reinforces our commitment to bringing effective treatments to the millions of patients who suffer from osteoporosis," David M. Reese, MD, executive vice president of research and development at Amgen, said in the release. "A patient with a prior osteoporotic fracture is twice as likely to suffer another fracture if left undiagnosed and without appropriate treatment. With this approval, physicians in Japan now have a new medicine to help patients reduce their risk of fracture."

Romosozumab works by binding and inhibiting the activity of the protein sclerostin and, as a result, has a dual effect on bone, both increasing bone formation and decreasing bone breakdown.

The approval is based on results from two phase 3 studies. In the FRAME study, researchers found that patients assigned romosozumab also showed improvements in bone mass, with sustained benefits following transition to denosumab (Prolia, Amgen) after 12 months. The study included 7,180 postmenopausal women with osteoporosis.

In the BRIDGE study, men with osteoporosis assigned to romosozumab showed significant BMD gains at the lumbar spine, total hip and femoral neck compared with placebo at 6 and 12 months, according to Amgen.

The Japanese Pharmaceuticals and Medical Devices Agency undertook a thorough review of the safety profile of romosozumab, including the cardiovascular safety findings in the ARCH trial, according to the release.

"In Japan, osteoporotic fracture is one of the leading causes for patients losing independence and needing nursing care,” Steve Sugino, Amgen vice president and president and representative director of AABP, said in the release. “As the aged population of Japan increases, preventing such fractures should be given high priority. Japanese patients will be the first in the world to have a new therapeutic option for osteoporosis that reduces the risk of fracture by not only increasing bone formation but also decreasing bone resorption."

The FDA and the European Medicines Agency are reviewing marketing applications for romosozumab, and interactions with the agencies are ongoing. The FDA Bone, Reproductive and Urologic Drugs Advisory Committee will meet on Wednesday, Jan. 16, to discuss the biologics license application for romosozumab in the United States.

In July 2017, the FDA issued a complete response letter for the biologics license application for romosozumab, asking Amgen to add safety and efficacy data from the ARCH and BRIDGE studies into the drug application. The original application, submitted to the FDA in September 2016, was based on efficacy and safety data from the FRAME study.

Amgen and UCB are co-developing the drug, with development in Japan led by Amgen Astellas BioPharma K.K., a joint venture between Amgen and Astellas Pharma Inc., headquartered in Tokyo. – by Regina Schaffer

Disclosures: The authors report no relevant financial disclosures.

The Japanese Ministry of Health, Labor and Welfare granted a marketing authorization this week for the monoclonal antibody romosozumab for the treatment of osteoporosis in patients at high risk for fracture, Amgen and UCB Pharma announced in a press release.

"The approval of Evinity in Japan is a significant milestone that reinforces our commitment to bringing effective treatments to the millions of patients who suffer from osteoporosis," David M. Reese, MD, executive vice president of research and development at Amgen, said in the release. "A patient with a prior osteoporotic fracture is twice as likely to suffer another fracture if left undiagnosed and without appropriate treatment. With this approval, physicians in Japan now have a new medicine to help patients reduce their risk of fracture."

Romosozumab works by binding and inhibiting the activity of the protein sclerostin and, as a result, has a dual effect on bone, both increasing bone formation and decreasing bone breakdown.

The approval is based on results from two phase 3 studies. In the FRAME study, researchers found that patients assigned romosozumab also showed improvements in bone mass, with sustained benefits following transition to denosumab (Prolia, Amgen) after 12 months. The study included 7,180 postmenopausal women with osteoporosis.

In the BRIDGE study, men with osteoporosis assigned to romosozumab showed significant BMD gains at the lumbar spine, total hip and femoral neck compared with placebo at 6 and 12 months, according to Amgen.

The Japanese Pharmaceuticals and Medical Devices Agency undertook a thorough review of the safety profile of romosozumab, including the cardiovascular safety findings in the ARCH trial, according to the release.

"In Japan, osteoporotic fracture is one of the leading causes for patients losing independence and needing nursing care,” Steve Sugino, Amgen vice president and president and representative director of AABP, said in the release. “As the aged population of Japan increases, preventing such fractures should be given high priority. Japanese patients will be the first in the world to have a new therapeutic option for osteoporosis that reduces the risk of fracture by not only increasing bone formation but also decreasing bone resorption."

The FDA and the European Medicines Agency are reviewing marketing applications for romosozumab, and interactions with the agencies are ongoing. The FDA Bone, Reproductive and Urologic Drugs Advisory Committee will meet on Wednesday, Jan. 16, to discuss the biologics license application for romosozumab in the United States.

In July 2017, the FDA issued a complete response letter for the biologics license application for romosozumab, asking Amgen to add safety and efficacy data from the ARCH and BRIDGE studies into the drug application. The original application, submitted to the FDA in September 2016, was based on efficacy and safety data from the FRAME study.

Amgen and UCB are co-developing the drug, with development in Japan led by Amgen Astellas BioPharma K.K., a joint venture between Amgen and Astellas Pharma Inc., headquartered in Tokyo. – by Regina Schaffer